Is Government to Regulate OXYTOCIN ?

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To curb the misuse of the drug by dairy owners and farmers, who use it to boost milk production and increase the size of vegetables. The Central Drugs Standard Control Organization (CDSCO) proposes to regulate the supply of Oxytocin injection to only one manufacturer, a move that would hit other domestic manufacturers.

Oxytocin is an important chemical messenger that controls some human behaviors and social interaction. It is oxytocin that triggers the bond between a mother and an infant, and it may also play a role in recognition, sexual arousal, trust, and anxiety. Oxytocin is a powerful hormone that acts as a neurotransmitter in the brain. It regulates social interaction and sexual reproduction, playing a role in behaviors from maternal-infant bonding and milk release to empathy , generosity , and orgasm. When we hug or kiss a loved one, oxytocin levels increase; hence, oxytocin is often called "the love hormone." In fact, the hormone plays a huge role in all pair bonding. The hormone is greatly stimulated during sex, birth, and breastfeeding. Oxytocin is the hormone that underlies trust. It is also an antidote to depressive feelings.

For all its positivity, however, oxytocin has a dark side. Or, more accurately, it plays a more complex role in human behavior than is commonly thought. As a facilitator of bonding among those who share similar characteristics, the hormone fosters distinctions between in-group and out-group members, and sets in motion favoritism toward in-group members and prejudice against those in out-groups. Ongoing research on the hormone is a potent reminder of the complexity of biological and psychological systems.

Understanding oxytocin will help you take better care of your health and lead you toward a better understanding of how your body functions.

For men, oxytocin function is less important, but it does have a role to play in moving sperm. It also appears to affect the production of testosterone in the testes.

With drug firms and pharma lobby groups raising their objections, the matter of how to ensure effective regulation and restriction on manufacturing and sales of oxytocin will now be taken up by the Government’s think tank NITI Aayog, along with experts from the ministries of agriculture, health, science and technology, and the department of revenue.

Oxytocin is prescribed for the initiation of uterine contractions and induction of labour in women as well as stimulation of contractions during labour.

It is also used to help abort the foetus in cases of incomplete abortion or miscarriage, and control bleeding after childbirth. But it is controversial because it is used widely in the dairy industry, agriculture and horticulture. Authorities are also concerned that the misuse of this growth booster is reported among trafficked children, injected to accelerate puberty among girls. The minister for women and child development, Maneka Gandhi, has been pushing for a ban and had taken up the issue with health minister J.P. Nadda.

The Government’s top drug advisory board—the Drug Technical Advisory Board (DTAB)—in a meeting on 12 February recommended various measures to check the drug’s misuse. Other than proposing curbs on imports, it also proposed the drug be manufactured by only one firm, Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL), a public sector unit, and be marketed by another, HLL Lifecare Ltd. “The other manufacturers will henceforth have to stop production,” two people in the know said.

According to CDSCO, currently there are 80 licenced manufacturers including pharma major Pfizer and Novartis and there is only one manufacturer of oxytocin active pharmaceutical ingredient (API). Oxytocin is included as a lifesaving drug in the National List of Essential Medicines (NLEM) and hence according to pharma lobby group Indian Drug Manufacturers’ Association (IDMA), its regulation will lead to “shortages” and “widespread panic”. In their representation to the CDSCO, the IDMA raised concerns over the illegal trade of oxytocin. “Oxytocin API is reportedly widely smuggled into the country, mainly from China and formulated by illegitimate and unlicensed formulators. Government must focus on curbing smuggling of oxytocin API,” it said.

The drug cannot be banned for its beneficial medical use.

“Banning its import is not a solution. It requires strict regulation. It is an internationally established first line drug used for active management of third stage labour and there is no substitute,” said B.R. Sikri, President of Federation of Pharmaceutical Entrepreneurs (FOPE).

A senior executive of a leading pharma company who did not wish to be named said the government’s policy of restricting the drug is a “matter of concern” for private drug makers and government needs to rethink their strategy.

“What do we do with the stock of API lying with us. Also it won’t be feasible for one manufacturer to fulfil the demand. The drug is under NLEM and costs about Rs.15-16. It will be a costlier affair for any one company to market the drug effectively; the price cannot be justified. Why can’t Government regulate this substance similar to psychotropic substance instead of completely pushing off private players?” he asked.

While Pfizer Inc.’s spokesperson said that they would be fully supportive of any measures that curtail ‘clandestine import’, ‘unlicensed manufacturing’ and ‘illegal sale’ . However, As such, the availability of this medicine for prescribed human use, and the legitimate manufacturing & distribution of this medicine by pharmaceutical companies with valid licenses and in compliance with Government regulations should not be compromised.